Clearance Summary
16 Breast Coil received FDA 510(k) clearance under submission number K233348, sponsored by Philips Medical System Nederlands B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-10-24.
- Submission: K233348
- Applicant / Sponsor: Philips Medical System Nederlands B.V.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2023-10-24
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.